inforMED
InjuryFEF

BLAKEMORE TUBE

Received Feb 24, 1998

Report 8010092-1998-00005 · MDR key 151941

Device

Generic name

Sengstaken Tube

Model number

NA

Catalog number

230021

Lot number

UNK

Product problems

  • Balloon leak(s)

Patient

UNKNOWN

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

IT HAS BEEN RPEORTED THAT ONE DEVICE HAD A LEAK IN THE STOMACH BALLOON PRIOR TO USE AND ANOTHER TWO DEVICES DEVELOPED LEAKS IN THE SAME PLACE AFTER INSERTION. SEVERAL TELEPHONE CALLS TO THE HOSP HAVE BEEN MADE TO OBTAIN FURTHER INFO. NO SUCCESS AS YET.